Quality Assurance Document Control Specialist

16 hours ago


Bothell WA USA, United States Hire Aviation Staffing Solutions LLC Full time
Job Title: Quality Assurance Document Control Specialist

Location: Bothell, WA

Job Summary:

We are seeking a highly organized and detail-oriented Quality Assurance Document Control Specialist to support our cGMP Document Control operations. The successful candidate will be responsible for managing document change control, issuing and reconciling batch records, and ensuring compliance with regulatory requirements.

Key Responsibilities:
  • Manage document change control process, including reviewing and approving document change requests
  • Issue and reconcile batch records, batch-related forms, and product labels
  • Manage archival and retention of GMP records
  • Assist with cross-training of Document Control personnel and customers
  • Support internal and external audits and regulatory inspections
  • Perform Document Control metric reporting and analysis
Requirements:
  • Minimum of 1 year of relevant document control management experience in a cGMP/FDA regulated environment
  • Strong communication and customer service skills
  • Technical writing skills and ability to critically review documents
  • Strong computer skills with MS Office and Quality Systems
  • Ability to work effectively and collaboratively at a fast pace
Preferred Qualifications:
  • Experience interacting with FDA or other regulatory agencies
  • Strong knowledge of cGMPs and domestic regulatory requirements
  • Knowledge of manufacturing quality
Working Conditions:

Employees holding this position will be required to perform job-related duties supporting the Manufacturing Operations, related to batch documentation to support the various Manufacturing shifts. Weekend and off-shift support may be required.



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